Changzhou Bomedent Medical Technology Co., Ltd.
Registered establishment in Changzhou, Jiangsu, China. 6 device types, 3 clearances.
Changzhou Bomedent Medical Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Locator, Root Apex, Scaler, Ultrasonic and 4 other device types. Its earliest product listing with the FDA dates from 2020.
6device types registered with the FDA
3510(k) clearances
Registration
| Registered name | CHANGZHOU BOMEDENT MEDICAL TECHNOLOGY CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3017618678 |
| FEI number | 3017618678 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 常州博美医疗科技有限公司 |
|---|---|
| Source | Baidu Baike |
Location
| City | Changzhou |
|---|---|
| Province | Jiangsu |
| Address | NO.9 Changyang road, West Taihu Science Techology Industrial Park |
| Postal code | 213100 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Handpiece, Direct Drive, Ac-Powered | Class 1 | Dental Electrical Motor iRoot Pro | 2020 | 10 |
| Instrument, Cutting, Operative | Class 1 | Endodontic Obturation Devices | 2021 | 5 |
| Instrument, Filling, Plastic, Dental | Class 1 | Endodontic Obturation Devices | 2021 | 23 |
| Locator, Root Apex | Class U | BOMEDENT Apex locator, WISMY Apex locator, Dental Electrical Motor iRoot Pro | 2020 | 8 |
| Preparer, Root Canal Endodontic | Class 1 | SCM-019, iBon, iBon Mini, iBon Mini-SE | 2023 | 8 |
| Scaler, Ultrasonic | Class 2 | Ultrasonic Endo Activation Device (Model: Actor I pro) | 2022 | 14 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K213947 | 2022-09-08 | ELC | Traditional | This company |
| K203836 | 2021-03-30 | LQY | Traditional | This company |
| K191276 | 2020-06-30 | EKX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Dental motors, apex locators, endodontic devices, ultrasonic activation, root canal treatment units |
|---|---|
| Certifications | ISO 13485, MDD, MDR |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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